Amid escalating concerns about the potential health impacts of breast implants, the U.S. Food and Drug Administration released draft guidance on Wednesday recommending stronger warnings for the devices.
The FDA said manufacturers should use “black box” warnings ― the agency’s most stringent form of labeling ― to inform people of possible risks and complications from breast implants, including rare cancers and a need for additional surgeries.
The FDA said the boxed warnings should also include language indicating that breast implants are not lifetime devices and that the odds of complications increase over time. The agency additionally recommended that people considering breast implants be provided with a “patient decision checklist” that would include information about potential risks and benefits, as well as implant alternatives.
“We have heard from many women that they are not fully informed of the risks when considering breast implants,” Dr. Amy Abernethy, FDA principal deputy commissioner, and Dr. Jeff Shuren, director of the FDA’s Center for Devices and Radiological Health, said in a statement.
“The agency appreciates this important feedback and, in today’s draft guidance, has proposed a number of recommendations designed to help inform conversations between patients and health care professionals when breast implants are being considered,” the officials added.
The draft guidance ― subject to a 60-day public comment period before being finalized ― comes months after the FDA heard testimony from dozens of women who said they’d fallen ill after getting breast implants.
“We do not feel we have been effectively and appropriately informed,” cancer survivor Holly Davis, who got breast implants after a mastectomy, said during the FDA public advisory panel meeting in March.
Davis said she experienced chronic pain, rashes and hair and memory loss after the surgery ― symptoms that, she said, subsided after she finally removed her implants.
Some 400,000 people get breast implants every year in the United States, about a quarter of them as part of reconstruction after cancer surgery, The Washington Post reported. According to the FDA, up to 20% of breast implant patients have to have their implants removed within 8 to 10 years due to complications.
“Don’t ignore us. We are real,” Davis urged the panel, according to The New York Times.
The FDA said it’s received thousands of complaints from people who say their breast implants caused a slew of chronic health problems, including fatigue, muscle pain and insomnia. These health conditions are collectively referred to as “breast implant illness.”
Dr. Oren Lerman, director of the Aesthetic and Reconstructive Breast Surgery Fellowship at New York’s Lenox Hill Hospital, told USA Today that breast implant illness is a widespread problem, but one that continues to baffle physicians.
“We absolutely need more information on that,” Lerman said.
The FDA said some breast implants have also been linked to a rare cancer called breast implant-associated anaplastic large cell lymphoma (BIA-ALCL), a type of non-Hodgkin’s lymphoma.
“In most cases, BIA-ALCL is found in the scar tissue and fluid near the implant, but in some cases, it can spread throughout the body,” the regulator said in its draft guidance. “An individual’s risk of developing BIA-ALCL is considered to be low; however, this cancer is serious and can lead to death, especially if not treated promptly.”
Earlier this year, the FDA urged Allergan, the Irish pharmaceutical company, to recall its Biocell textured breast implants, which had been linked to a higher risk of BIA-ALCL. Allergan obliged, pulling the devices worldwide.
Diana Zuckerman, president of the nonprofit National Center for Health Research, told the Post that while the FDA’s new draft guidance is a “very important” step, she said it remains to be seen whether implant makers will abide. That, she said, depends “on how much pressure the FDA puts on the manufacturers.”
As FDA officials noted this week of the guidelines, “manufacturers may choose to follow the recommendations in the final guidance or they may choose other methods of labeling their devices, so long as the labeling complies with applicable FDA laws and regulations.”